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Breathe With Ease: A Unique Approach to Managing Stress (BEAMS)

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ClinicalTrials.gov Identifier: NCT02374138
Recruitment Status : Completed
First Posted : February 27, 2015
Results First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Stephen J. Teach, MD, MPH, Children's National Research Institute

Tracking Information
First Submitted Date  ICMJE February 10, 2015
First Posted Date  ICMJE February 27, 2015
Results First Submitted Date  ICMJE November 8, 2017
Results First Posted Date  ICMJE September 23, 2019
Last Update Posted Date September 23, 2019
Actual Study Start Date  ICMJE May 2015
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
Symptom-free Days in the Last 14 Days [ Time Frame: Repeated Measures at 6 months (3 month data collected to allow for repeated measures) ]
Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications
Original Primary Outcome Measures  ICMJE
 (submitted: February 26, 2015)
Symptom-free days [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
  • Asthma Morbidity - Nighttime Asthma Symptoms [ Time Frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures) ]
    Nights of asthma symptoms in prior 14d
  • Asthma Severity and Control [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
  • Asthma Medication Adherence [ Time Frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures) ]
    Reported use of inhaled corticosteroids and LTRA in past two days
  • Health Care Utilization - Emergency Department Visits for Asthma [ Time Frame: 12 months after enrollment ]
    Health care utilization - emergency department visits for asthma over six month and twelve month follow up periods. Reported as those documented in the electronic medical record of Children's National Health System plus parent report of visits elsewhere
  • Asthma Exacerbations - Courses of Systemic Steroids [ Time Frame: Assessed at 6m and 12m following enrollment ]
    Courses of systemic steroids over 12m follow up period
  • Parental Stress [ Time Frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures) ]
    Score on Perceived Stress Scale (PSS). The Perceived Stress Scale consists of 10 questions and is a measure of the degree to which situations in one's life are appraised as stressful. Scores range from 0 - 40, with higher scores indicating a higher level of perceived stress.
  • Parental Depression [ Time Frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures) ]
    Score on Center for Epidemiologic Studies Depression Scale (CES-D - 10). The CESD-10 scale screens for depressive symptoms. Scores range from 0-30, with higher scores indicating a higher degree of depressive symptoms.
  • Child Anxiety [ Time Frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures) ]
    PROMIS Parent Proxy Anxiety. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression.
  • Child Depression [ Time Frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures) ]
    PROMIS Parent Proxy Depressive Symptoms is a parent-report assessment of child depression. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression.
  • Caregiver Quality of Life [ Time Frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures) ]
    Caregiver quality of life score, assessed by modified Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ). The measure had five response options, with scores ranging from 13-65 and higher scores meaning better quality of life. No subscales were analyzed.
  • Number of Participants With AEs and SAEs [ Time Frame: 12m follow up period ]
    Safety data: Number of Participants with AEs and SAEs
  • Economic Outcomes [ Time Frame: 12m follow-up period ]
    Analysis of costs of care in both groups
  • Caregiver Smoking Behavior [ Time Frame: Repeated Measures at 6 and 12 months ]
    parent report of cigarettes smoked per day
  • Coping Strategies [ Time Frame: Repeated measures at 12m FU (6m data used for repeated measures) ]
    Brief COPE
  • Mindfulness [ Time Frame: Repeated Measures at 6 and 12 months ]
    Interpersonal Mindfulness in Parenting
  • Parental Resilience [ Time Frame: Repeated Measures at 6 and 12 months ]
    Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism.
  • Exacerbations - Hospital Admissions [ Time Frame: Assessed at 6m and 12m after enrollment ]
    Number of participants with hospital admissions due to exacerbations
  • Symptom-free Days in the Last 14 Days [ Time Frame: Repeated Measures at 12 months (with data also assessed at 3m and 6m) ]
    Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications
  • Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use [ Time Frame: Repeated measures at 6 and 12 months (3m data collected for repeated measures) ]
    Days of asthma symptoms, activity limitation, and quick relief medicine use in prior 14d
Original Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2015)
  • Asthma morbidity [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
  • Asthma Severity and Control [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
  • Asthma Medication Adherence [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
  • Health care utilization [ Time Frame: 24 months (12 months before and after enrollment) ]
    Utilization in 12m prior to enrollment and during 12m follow up period, including emergency department visits, hospital and ICU admissions, primary care visits, and urgent care visits.
  • Asthma exacerbations [ Time Frame: 24 months (12 months before and after enrollment) ]
    Courses of systemic steroids or hospitalizations in 12m prior to enrollment and during 12m follow up period
  • Parental Stress [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
    Perceived Stress Scale (PSS) and Stressful Life Events—Rochester Youth Development Study
  • Parental Depression [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
    Center for Epidemiologic Studies Depression Scale (CES-D)
  • Child Anxiety [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
    PROMIS Parent Proxy Anxiety
  • Child Depression [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
    PROMIS Parent Proxy Depressive Symptoms
  • Quality of life [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
    Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ)
  • Safety data: AEs and SAEs [ Time Frame: 12m follow up period ]
    AEs and SAEs
  • Economic Outcomes [ Time Frame: 12m follow-up period ]
    Analysis of costs of care in both groups
Current Other Pre-specified Outcome Measures
 (submitted: August 22, 2019)
  • Sociodemographics [ Time Frame: Baseline ]
    Age, gender, race, ethnicity, insurance type, parental education, household income, family medical history
  • Number of Participants With Positive Smoke Exposure [ Time Frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures) ]
    Participants with environmental smoke exposure. Responses were regrouped as negative (none) or positive (daily, often, or rarely) based on two questions: "How often did anyone smoke inside the home where child usually lives?" or "How often did anyone smoke in the room where child usually sleeps?" A positive response on either or both questions was considered positive exposure.
  • Parental Health Literacy [ Time Frame: Baseline ]
    Single Item Literacy Screener (SILS)
  • Use of Existing Ancillary Services [ Time Frame: Assessed at 6m and 12m following enrollment ]
  • Parental Resilience [ Time Frame: Baseline ]
    Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism.
  • Intervention Component Uptake [ Time Frame: 6 month intervention period ]
    Completion of intervention sessions
  • Intervention Satisfaction [ Time Frame: 6 month intervention period ]
    Brief survey of satisfaction with intervention components.
  • Intervention Fidelity [ Time Frame: 6 month intervention period ]
    Checklist of staff's fidelity to individual components of intervention protocol
Original Other Pre-specified Outcome Measures
 (submitted: February 26, 2015)
  • Sociodemographics [ Time Frame: Baseline ]
    Age, gender, race, ethnicity, insurance type, parental education, household income, family medical history
  • Environmental Smoke exposure [ Time Frame: Repeated Measures at 3, 6, and 12 months ]
    environmental smoke exposure
  • Parental Health Literacy [ Time Frame: Baseline ]
    Single Item Literacy Screener (SILS)
  • Use of Existing Ancillary Services [ Time Frame: Baseline and follow-up (3, 6, and 12m) ]
  • Parental Resilience [ Time Frame: Baseline ]
    Revised Life Orientation Test (LOT-R)
  • Intervention Component Uptake [ Time Frame: 6 month intervention period ]
    Completion of intervention sessions
  • Intervention Satisfaction [ Time Frame: 6 month intervention period ]
    Brief survey
  • Intervention Fidelity [ Time Frame: 6 month intervention period ]
    Checklist of staff's fidelity to individual components of intervention protocol
 
Descriptive Information
Brief Title  ICMJE Breathe With Ease: A Unique Approach to Managing Stress (BEAMS)
Official Title  ICMJE Improving Asthma Outcomes Through Stress Management
Brief Summary

Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients remain adherent to their management plans. Adherence to inhaled corticosteroids (ICS), when indicated for persistent or uncontrolled asthma, is a critical component of most asthma management plans, and other self-management practices such as trigger avoidance are similarly related to improved asthma outcomes. Adherence to self-management practices is mediated by multiple factors, including psychosocial stress of parents and their children.

A targeted, culturally appropriate intervention to manage psychosocial stress among the parents of young, African American, and socioeconomically disadvantaged urban children with asthma who are receiving guideline-based care may improve asthma self-management, and therefore asthma outcomes.

Our overall aim is to implement and evaluate a highly collaborative, multi-dimensional, culturally appropriate and community-based asthma intervention to augment existing guideline-based best practice. The intervention will target the parents of at-risk, urban, African American youth, and will employ individualized psychosocial stress management and peer support.

Detailed Description

Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients remain adherent to their management plans. Adherence to inhaled corticosteroids (ICS), when indicated for persistent or uncontrolled asthma, is a critical component of most asthma management plans, and other self-management practices such as trigger avoidance are similarly related to improved asthma outcomes. Adherence to self-management practices is mediated by multiple factors, including psychosocial stress of parents and their children.

A targeted, culturally appropriate intervention to manage psychosocial stress among the parents of young, African American, and socioeconomically disadvantaged urban children with asthma who are receiving guideline-based care may improve asthma self-management, and therefore asthma outcomes.

Our overall aim is to implement and evaluate a highly collaborative, multi-dimensional, culturally appropriate and community-based asthma intervention to augment existing guideline-based best practice. The intervention will target the parents of at-risk, urban, African American youth, and will employ individualized psychosocial stress management and peer support.

We will conduct a single blind, prospective randomized controlled trial comparing the IMPACT DC Asthma Clinic's existing intervention of guideline-based clinical care, education, and short-term care coordination (usual care) to usual care plus parental stress management in a cohort of up to 200 parent-child dyads of AA youth aged 4-12 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Behavioral: Parental stress management
    The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
  • Other: Usual Care
    IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination
Study Arms  ICMJE
  • Active Comparator: Usual Care
    IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination
    Intervention: Other: Usual Care
  • Experimental: Intervention
    Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.
    Intervention: Behavioral: Parental stress management
Publications * Teach SJ, Shelef DQ, Fousheé N, Horn IB, Yadav K, Wang Y, Rand CS, Streisand R. Randomized clinical trial of parental psychosocial stress management to improve asthma outcomes. J Asthma. 2019 Sep 23:1-12. doi: 10.1080/02770903.2019.1665063. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2017)
217
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2015)
168
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

We plan to enroll parent-child dyads that meet the following criteria:

Inclusion criteria (Parent):

  • self-identify as African-American
  • both the legal guardian and primary asthma caregiver of an eligible child.

Exclusion criteria (Parent):

  • unable or unwilling to sign informed consent document
  • exclusionary psychiatric condition, including but not limited to psychosis, based on the screening form at recruitment
  • enrolled in another asthma research study.

Inclusion criteria (Child):

  • parent-identified as African-American
  • age 4-12 years inclusive at recruitment
  • physician diagnosis of persistent asthma
  • publicly financed insurance

Exclusion criteria (Child):

- chronic medical condition (other than asthma) including but not limited to diabetes, sickle cell disease, heart disease, lung disease or neurological disorder.

In addition, the PI may choose to not include a participant if he does not believe it is in the family's best interest to participate.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02374138
Other Study ID Numbers  ICMJE 5819
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephen J. Teach, MD, MPH, Children's National Research Institute
Study Sponsor  ICMJE Stephen J. Teach, MD, MPH
Collaborators  ICMJE Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Stephen Teach, MD, MPH Children's National Health System
PRS Account Children's National Research Institute
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP